Kornimate/medical-research-clean huggingface dataset:
trial of art therapy during cognitive processing therapy for ptsd

Conditions: Post-traumatic Stress Disorder; Stress Disorder, Post-Traumatic

Summary: this is a randomized, controlled trial of adjunctive art therapy during cognitive processing therapy for ptsd.

the objective of this study is to examine the effects of art therapy with combat veterans who have ptsd and to measure if it reduces symptoms more than verbal cognitive processing therapy (cpt) alone. this study will incorporate art processes and materials into an already established protocol of cpt in order to create a sense of safety for veterans in beginning therapy, and access the nonverbal parts of the trauma in order to process it. art-making will be used to help veterans address trauma and integrate who they were before the trauma with who they are currently. it will assist in addressing the grief and loss caused by combat, and will be used as veterans begin building a worldview and self-concept that are not filled with trauma and war. it is hypothesized that the veterans who receive art therapy with cpt will show a significantly greater decrease in ptsd symptoms than those who receive only cpt.

Eligibility criteria:
inclusion criteria: * pcl-m initial score \>= 50; * both genders, * all ethnicities, * veterans in treatment for ptsd, exclusion criteria: * no active substance use disorder, * no active suicidal or homicidal ideation, * no psychosis

Keywords: ptsd
effect of 3d movie viewing on stereopsis in strabismus and / or anisometropic amblyops

Conditions: Amblyopia; Anisometropic Amblyopia; Strabismic Amblyopia

Summary: this study evaluates the effect of 3d movie viewing on stereopsis recovery in anisometropic and / or strabismus amblyopia and the satisfaction with the intervention.

amblyopia is a visual neurodevelopmental disorder associated, more frequently, with the presence of strabismus and anisometropia. it is clinically most important visual condition in childhood because, apart from refractive error, it is the most frequent cause of vision loss in children. it is a reversible condition that affects up to 5% of the population, and that is the result of an abnormal visual experience during the most sensitive period of visual development. although amblyopia is expressed in the clinical practice as a reduction in visual acuity, it is also characterized by an altered stereoscopy. generally, treatments for amblyopia focus on the recovery of visual acuity, and there are no treatments that focus mainly on the recovery of the altered stereopsis, so present and with an important functional impact. the aim of this study reviewing, analyzing and, if applicable, updating the current treatment model for amblyopia. on the one hand, to evaluate the effectiveness of viewing a 3d movie in the improvement of stereoacuity and the deviation, as well as visual acuity and sensitivity to contrast. also, the correlation between them. on the other hand, to assess quantitatively the degree of satisfaction and acceptance of the participants and their families towards the intervention. a quasi-experimental study will be performed, without a control group, pre- and post- intervention in which subjects with refractive and / or strabismus amblyopia, that have been subjected to traditional treatment for amblyopia, will be selected. variables of stereopsis, latent or manifest deviation, visual acuity and sensitivity to the contrast will evaluate previously and after the intervention. the sample will include subjects between 5 to 12 years old with a diagnosis of refractive and / or strabismic amblyopia.

Eligibility criteria:
inclusion criteria: * diagnosis of refractive and / or strabismus amblyopia at some point in life * history of amblyopia treatment completed at least 6 months before the intervention * deviation angle equal to or less than 10 dp * absence of associated ophthalmological pathology. exclusion criteria: * ongoing amblyopia treatment; * non-comitant and/or large constant strabismus (\>10 prism diopters) * any ocular pathological condition or nystagmus.

Keywords: 3d movies amblyopia treatment
pacing in heart failure with preserved lvef

Conditions: Heart Failure

Summary: a random-order cross-over pilot trial of a ce marked device (pacemaker) outside its current intended purposes. the study will comprise 10 patients. recruitment of patients will take place from the university hospital of wales (cardiff \& vale university health board \[cvuhb\]). all patients recruited will have septal flattening during exercise demonstrated using contrast stress (exercise) echocardiography. all 10 patients will be implanted with a crt-pacemaker device and will be tested on all three of the following settings on separate visits (with a gap of up to 5 days between visits) in random order: routine medical therapy routine medical therapy + lvp routine medical therapy + bivp


Eligibility criteria:
inclusion criteria: 1. clinical features consistent with heart failure. all patients will have symptoms of moderate to severe heart failure with new york heart association (nhya) classification iii or iv symptoms (for at least 3 months). 2. lv ejection fraction less or equal to 50%, with no evidence of significant valvular disease, no hypertrophic or restrictive cardiomyopathy, and no evidence of pericardial constriction. 3. additionally all patients will have demonstrated evidence of septal flattening during exercise using contrast echocardiography. 4. adults (over 18 years) 5. negative test for covid during surgical pre-assessment, and adherence to prescribed self-isolation before implantation. 6. two weeks or more following final dose of vaccination against coronavirus. exclusion criteria: 1. inability to provide informed consent. 2. enrolment in other clinical studies. 3. bmi more than 35 4. objective evidence of significant lung disease on formal lung function testing 5. previous (within three months) or scheduled coronary revascularisation or other cardiac surgery 6. acute coronary syndrome (within the previous three months) 7. history of atrial fibrillation (af) 8. renal insufficiency requiring haemodialysis 9. life expectancy less than 6 months 10. prosthetic heart valves 11. blood coagulation disorders 12. immunocompromised patients (e.g. aids, patients on steroids, cytotoxic drugs, and radiation therapy) 13. currently pregnant, or intending to conceive. 14. recent positive covid test (up to 14 days prior to pre-assessment).
biologics in chronic rhinosinusitis with nasal polyposis

Conditions: Chronic Sinusitis; Nasal Polyps

Summary: the prevalence of chronic sinusitis with nasal polyps (crswnp) in the united states is estimated at roughly 4%, which equates to over 13 million americans. until recently, the only medical treatment options available for patients with crswnp were corticosteroids, with surgery reserved for medical failure. the development of biologic medications over the last 5 years has revolutionized the treatment of crswnp. three biologic medications have been fda approved and available for the treatment of crswnp: dupilumab, omalizumab, and mepolizumab. however, data from the clinical trials for these drugs do not show universal improvement across all patients with crswnp. in fact, there is a wide range of outcomes for patients in these trials. the result is that clinicians have no way of knowing which specific biologic would be the best option for any given patient, nor do they know whether biomarkers can be used to predict response to biologics. it is hoped that findings from this study will inform whether any one biologic has superior outcomes to another and whether clinicians can identify patients at baseline who are most likely to improve on biologic therapy.


Eligibility criteria:
inclusion criteria: * age \> 18 years * confirmed diagnosis of chronic rhinosinusitis with nasal polyposis using icar-21 (international consensus statement 20215) criteria * bilateral nasal polyposis visible on sinonasal endoscopy * nasal polyp score \> 5 * baseline snot-22 total score \> 30 * patient elects biologic therapy for the management of crswnp * capable of receiving all 3 biologic therapy medications. * treatment with intranasal mometasone ≥200 μg. once daily (or equivalent of another intranasal corticosteroid) for 1-month prior to baseline visit. exclusion criteria: * inability or unwillingness of a participant to give written informed consent or comply with study protocol * endoscopic sinus surgery within 6-months preceding enrollment / randomization. * oral corticosteroid use within 30-days preceding enrollment / randomization. * serum ige level outside the dosing range for omalizumab (i.e., \<30 iu/ml. or a weight-based dose with insufficient data to determine dose as per fda dosing chart) * comorbid atopic dermatitis, urticaria, or any other condition that would require a specific biologic per the standard of care. * currently pregnant or plan to become pregnant within the 6 months after enrollment / randomization. * any previous treatment with any of the 3 biologic medications. * comorbid cystic fibrosis, cvid, or ciliary dyskinesia. * comorbid systemic inflammatory disorders (e.g., gpa, egpa, sarcoidosis, sle) * past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks for participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study.

Keywords: sinusitis biologics
multi-center trial of ferric derisomaltose versus no intravenous iron in iron-deficient subjects with symptomatic chronic heart failure

Conditions: Chronic Heart Failure; Iron Deficiencies

Summary: the goal of this clinical trial is to learn if the iv iron treatment ferric derisomaltose helps in the treatment of chronic heart failure in people with iron deficiency. the main question it aims to answer is: • how many participants are admitted to the hospital or die from a disease in the heart or blood vessels researchers will compare treatment with ferric derisomaltose to no treatment with ferric derisomaltose. this will be done to see how well ferric derisomaltose works. participants will: * be randomized 50/50 to either treatment with ferric derisomaltose or to no treatment with ferric derisomaltose * all participants receives standard of care * visit site 4-5 times and have 7 video/phone-calls


Eligibility criteria:
inclusion criteria: * 18 years or older * both women and men can join * heart failure that causes fatigue, shortness of breath, or other symptoms during physical activity * have left ventricle (chamber) ejection fraction (pumping ability) that is 45% or less * have low iron levels in the blood * new york heart association (nyha) heart failure classification ii, iii or iv exclusion criteria: * planned cardiac surgery or revascularization or cardiac device implantation * pregnant or nursing women * treatment with iron intravenous (through the vein) or intramuscular (injection in the muscle) within the past 6 months * treatment with radiotherapy or chemotherapy
prognosis of patients with upper tract urothelial carcinoma receiving kidney-sparing therapy

Conditions: Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy

Summary: upper tract urothelial carcinoma (utuc) is a rare malignant disease which accounts for 5-10% of urothelial carcinoma in the western world and 9%-30% in china. about two thirds of patients have muscle invasive disease at diagnosis. those patients usually have poor prognosis. the 5 year cancer specific survival is \<50% for pt2/t3 and \<10% for pt4. radical nephroureterectomy is the standardized treatment for non-metastatic high risk utuc. however, about half patients may suffer from impaired renal function after nephroureterectomy. on the other hand, kidney sparing surgery can avoid renal function impairment, but the therapy is only recommended for few patients with low-risk disease. the treatment for urothelial carcinoma has changed rapidly in the past few years. immune checkpoint inhibitors and novel agents such as adcs have shown promising therapeutic effect and were approved for patients with metastatic utuc. meanwhile, a recent study shows that patients with high-risk disease can also receive kidney sparing surgery without compromising cancer specific survival and overall survival. this prospective, observational study aims to evaluate the prognosis of contemporary kidney sparing surgery in patients with utuc with or without perioperative therapy in the real world.

the patients that meet the inclusion and exclusion criteria will enroll into this observational trial. the therapeutic schedule is purposed to spare the kidney of non-metastatic primary utuc patients.

Eligibility criteria:
minimum age: 18 years maximum age: 90 years sex: all gender based: no accepts healthy volunteers: no criteria: inclusion criteria: 1. histopathological confirmed upper tract urothelial carcinoma; 2. refused radical nephroureterectomy, or eligible for the indications of kidney-sparing surgery; 3. participants must be willing to attend the follow-up visits; 4. sign informed consent. exclusion criteria: 1. unable to undergo kidney-sparing surgery; 2. life expectancy \< 6 months; 3. previous anti-tumor therapy against utuc, including systemic chemotherapy, surgery, radiotherapy, or immunotherapy identifying by investigators.

Keywords: kidney-sparing therapy upper tract urothelial carcinoma
a pilot study to evaluate skin swabbing with chlorhexidine to prevent skin and soft tissue infections among people who inject drugs

Conditions: Opioid Use Disorder; Infection Control and Prevention; Injection Drug Use

Summary: the study examined chlorhexidine gluconate (chg) swabs as a skin disinfectant in combination with a single-session safer injection training to prevent skin and soft tissue infections (ssti) in people who inject drugs.

skin and soft tissue infections (ssti) are a serious and preventable complication of intravenous drug use, yet few interventions have been developed to reduce ssti in people who inject drugs (pwid). this study tested two interventions to reduce ssti in pwid: 1) a single-session behavioral intervention to inculcate skin swabbing behaviors, and 2) chlorhexidine swabs to be used as for cleaning the skin prior to injecting.

Eligibility criteria:
inclusion criteria: * self-report intravenous drug use within past 30 days exclusion criteria: * none

Keywords: opioid use disorder injection drug use skin and soft tissue infection chlorhexidine people who inject drugs
a study on factors of biochemical response in autoimmune hepatitis

Conditions: Autoimmune Hepatitis

Summary: the goal of this observational study is to clarify the clinical characteristics of autoimmune hepatitis (aih) in china. the main questions it aims to answer are: human leukocyte antigen (hla) gene susceptibility in chinese aih patients prognostic factors associated with aih participants will provide liver tests results and details of treatment during follow-up.

this study aims to establish a high-quality, standardized prospective cohort of aih with regular follow-up, clarify the clinical characteristics of aih in china, construct a prognostic model, and explore new serum markers or aih gene susceptibility, so as to provide key clinical evidence for the prevention and treatment of aih in china.

Eligibility criteria:
inclusion criteria: 1. ≥18 years old at the time of onset; 2. aih simplified score ≥6 and/or aih revised score ≥10; 3. liver biopsy was performed and consistent with the pathological diagnosis of aih; 4. patents were treatment naive or who were diagnosed and treated in other hospitals but have stopped glucocorticoid/immunosuppressive therapy for more than 3 months; 5. agree to participate in this study and sign the informed consent form. exclusion criteria: 1. concomitant liver diseases: hepatotropic viral hepatitis (a, b, c, d, and e) and non-hepatotropic viral hepatitis (cytomegalovirus and epstein-barr virus (ebv) infection); 2. concomitant with drug-induced liver injury, primary biliary cholangitis, primary sclerosing cholangitis, alcoholic liver disease, genetic and metabolic liver diseases; 3. bone marrow or liver transplantation; 4. incomplete baseline medical history and laboratory examination results; 5. for previously diagnosed patients, immunosuppressive therapy was discontinued less than 3 months; 6. pregnancy or lactation; 7. patients with contraindications to glucocorticoid/immunosuppressive therapy; 8. complicated with other malignant tumors; 9. complicated with mental disorders.

Keywords: autoimmune hepatitis biochemical response prognosis immunosuppressive therapy
adaptation processes in school-based substance abuse prevention

Conditions: Substance Abuse Problem

Summary: the purpose of this study is to determine if a new substance use prevention curriculum for rural middle schools is effective in reducing substance use and to study how prevention curriculum get implemented by teachers.

the goals of the proposed study are to conduct an effectiveness trial of the keepin' it real (refuse, explain, avoid, leave) middle school substance use prevention curriculum among a new target audience in rural pennsylvania and ohio, describe how teachers adapt the curriculum when they present it, and develop, implement, and evaluate a pennsylvania/ohio-version of the curriculum to test whether an evidence-based universal curriculum can be improved by adapting it to local cultures. keepin' it real is recognized as a "model program" by samhsa's (substance abuse and mental health services administration's) national registry of effective programs and is one of the few that are multicultural. the study will evaluate the effectiveness of the original curriculum, grounded in the cultures of the southwest and compare that to a new version, "re-grounded" in the rural culture of pennsylvania and ohio, while studying how teachers adapt both versions. this proposal responds to nida (national institute on drug abuse) pa-05-118 (program announcement), drug abuse prevention intervention research that calls for investigations addressing, "1) the development of novel drug abuse prevention approaches; 2) the efficacy and effectiveness of newly developed and/or modified prevention programs; 3) the processes associated with the selection, adoption, adaptation, implementation, sustainability, and financing of empirically validated interventions." this proposal addresses all three points. a randomized control trial will be conducted in middle schools to accomplish these goals. first, formative research will be conducted to develop a rural pennsylvania/ohio-version of the curriculum. second, 39 rural schools will be randomly assigned to one of three conditions: teacher adaptation in which the original keepin' it real curriculum is implemented; researcher adaptation in which a new pennsylvania-version of the curriculum is implemented, and a control group. we hypothesized the participation in either form of the curriculum will reduce drug use and that the researcher adaptation will produce better outcomes and less teacher adaptation than the teacher adaptation. a pretest will be administered followed by post-tests in 7-9th grades. adaptation and fidelity will be measured in 3 ways: teachers completing a program quality and adaptation online measure after each lesson, videotaped lessons, and attendance. the major hypothesis tests will be conducted using variants of the general linear model, taking into account the multilevel structure of the data, test of a mediation model, and growth modeling.

Eligibility criteria:
inclusion criteria: - all 7th grade students in implementation middle exclusion criteria: * lack of parental consent * lack of student assent

Keywords: rural adolescents, substance use, prevention, adaptation
five-year changes in patients with chronic stroke

Conditions: Chronic Stroke

Summary: objective of the study: * to determine changes in physical and cognitive function in patients with chronic stroke over 5 years * to determine whether there are differences in physical and cognitive function in chronic stroke patients with different baseline levels of physical activity


Eligibility criteria:
inclusion criteria: - stroke patients whose physical activity was assessed in 2018 - 2019 (previous research study) exclusion criteria: - none
act-293987 in pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: long-term, single-arm, multicenter, open-label extension, phase 3 study, to evaluate the safety and tolerability of act-293987 in patients with pah who participated in the double-blind study ac-065a302 (griphon)


Eligibility criteria:
inclusion criteria: * patients who participated to the double-blind study ac-065a302 and either had a morbidity event or had completed the study as scheduled per protocol. * signed informed consent. exclusion criteria: * patients who have started receiving prostacyclin (epoprostenol) or prostacyclin analogs (i.e., treprostinil, iloprost, beraprost) since the last study drug intake in ac-065a302/griphon. * severe hepatic impairment (child-pugh c). * females who are pregnant or who plan to become pregnant during the study, or are breastfeeding. * any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results, such as drug or alcohol dependence, or psychiatric disease.

Keywords: open-label pah pulmonary arterial hypertension
propofol versus dexmedetomidine for prevention of sevoflurane agitation in recipients of living donor liver transplantation

Conditions: Liver Transplantation

Summary: the use of propofol or dexmedetomedine for prevention of sevofurane emergence agitation in ldlt recipients


Eligibility criteria:
inclusion criteria: * all recipients of living donor liver transplantation exclusion criteria: * patient refusal allergy to either propofol or dexmedetomediene cns disease

Keywords: recipients
effect of pre-warming on perioperative hypothermia during holepunder spinal anesthesia

Conditions: Hypothermia

Summary: inadvertent perioperative hypothermia is an unintentional drop in core body temperature below 36°c. intraoperative hypothermia can lead to serious clinical complications such as, myocardial ischemia, coagulopathy, immunosuppression, and surgical wound infection. hypothermia develops easily during surgeries that require irrigation fluid, such as laparoscopic surgery and transurethral resection of the prostate. although isothermic irrigation fluid was suggested to prevent perioperative hypothermia, it can be difficult to warm a large volume of irrigation fluid. re-distribution after induction of anesthesia is the most important cause of perioperative hypothermia. the extent of re-distribution is proportional to the gradient between the core and peripheral compartments. pre-warming increases the heat content of the peripheral thermal compartment, reducing the gradient for redistribution. recently, a recent-meta analysis suggested that as a single strategy, preoperative forced air warming had significant benefits than other warming methods. also, it was reported that only 20 (or even 10) min of pre-warming mostly prevented patients from perioperative hypothermia under general anesthesia. however, few studies have examined whether short time pre-warming can reduce hypothermia due to a large amount of irrigation fluid during surgery under spinal anesthesia. the purpose of this study is to assess whether the application of preoperative forced air warming set to high temperature (\> 43°c) for brief period can prevent hypothermia or shivering during procedures requiring large volumes of cold irrigation.


Eligibility criteria:
inclusion criteria: * adult patients with asa physical status i-iii, aged 50 - 80 years, undergoing holep under spinal anesthesia exclusion criteria: * preoperative body temperature of more than 37.2°c preexisting severe cardiovascular, respiratory and endocrinal disease on anticoagulant therapy